With more than eight million people in the United States living with psoriasis, approximately one-third of whom also have psoriatic arthritis, it is essential for clinicians to remain informed about emerging clinical trial opportunities and resulting data that may inform therapeutic strategies, affect clinical guidelines, expand treatment options, and ultimately improve patient quality of life.
Today, we have a rundown of eight Phase 3 clinical trials on psoriatic arthritis that are currently recruiting in the United States.
Quick View Table of Psoriatic Arthritis Clinical Trials
| Study Title | Estimated Enrollment | Start Date | Estimated Completion Date |
|---|---|---|---|
| Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis | 650 | June 2022 | April 2029 |
| A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis (ICONIC-PsA 1) | 540 | February 2025 | November 2028 |
| A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced Participants With Active Psoriatic Arthritis (ICONIC-PsA 2) | 750 | January 2025 | October 2028 |
| A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines | 1088 | March 2025 | January 2028 |
| A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines | 600 | March 2025 | January 2028 |
| Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response (IZAR-2) | 600 | October 2024 | January 2027 |
| Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug (IZAR-1) | 960 | October 2024 | January 2027 |
| Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients (EVOLUTION) | 63 | July 2023 | October 2026 |
Phase 3 Clinical Trials
Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis
- Sponsor: Sun Pharmaceutical Industries Limited
- Goal: An open label phase 3 study. Subjects from both INSPIRE 1 (TILD-19-07) and INSPIRE 2 (TILD-19-19) studies to roll over into this INSPIRE LTE study (TILD-21-01).
- Interventions: TILD sub-cutaneous (SC) injection
- Primary Outcome Measures: Incidence and intensity of adverse events (AEs) recorded through the study period; Proportion of subjects who reached (American College of Rheumatology Score of 20) ACR20; Proportion of subjects who reached (American College of Rheumatology Score of 50) ACR50; Proportion of subjects who reached (American College of Rheumatology Score of 70) ACR70.
- Time Frames: Week 124; Week 124; Week 124; Week 124.
- Study Details
- Source
A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis (ICONIC-PsA 1)
- Sponsor: Jannssen Research & Development
- Goal: The purpose of this study is to evaluate the efficacy of icotrokinra compared to placebo in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
- Interventions: icotrokinra, placebo, active reference comparator
- Primary Outcome Measures: Proportion of participants who achieve an American College of Rheumatology (ACR) ACR 20 response at Week 16
- Time Frame: Week 16
- Study Details
- Source
A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced Participants With Active Psoriatic Arthritis (ICONIC-PsA 2)
- Sponsor: Janssen Research & Development
- Goal: The purpose of this study is to evaluate the efficacy of icotrokinra compared to placebo in biologic-experienced participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
- Interventions: icotrokinra, placebo
- Primary Outcome Measures: Proportion of participants who achieve an American College of Rheumatology (ACR) ACR 20 response at Week 16
- Time Frame: Week 16
- Study Details
- Source
A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines
- Sponsor: Takeda
- Goal: The main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA who have not previously been treated with biologic disease-modifying antirheumatic drugs.
- Interventions: zasocitinib, active comparator, placebo
- Primary Outcome Measure: Percentage of participants achieving American College of Rheumatology 20 (ACR20) response at week 16 for aasocitinib dose A and B compared to placebo
- Time Frame: At week 16
- Study Details
- Source
A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines
- Sponsor: Takeda
- Goal: The main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA based on their previous experience with specific treatments.
- Interventions: zasocitinib, placebo
- Primary Outcome Measure: Percentage of participants achieving American College of Rheumatology 20 (ACR20) response at week 16 for zasocitinib dose A and B compared to placebo
- Time Frame: At week 16
- Study Details
- Source
Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response (IZAR-2)
- Sponsor: MoonLake Immunotherapeutics
- Goal: This is a study to confirm the clinical efficacy and safety of sonelokimab compared with placebo in the treatment of adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.
- Interventions: sonelokimab, placebo, risankizumab
- Primary Outcome Measure: Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)
- Time Frame: Week 16 compared to placebo
- Study Details
- Source
Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug (IZAR-1)
- Sponsor: MoonLake Immunotherapeutics
- Goal: This is a study to demonstrate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult patients with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy.
- Interventions: sonelokimab, placebo
- Primary Outcome Measure: Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)
- Time Frame: Week 16
- Study Details
- Source
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients (EVOLUTION)
- Sponsor: University of Pennsylvania
- Goal: The trial is an open-label randomized study that will examine whether switching to a selective IL23 inhibitor (guselkumab) is more effective than switching to a second TNFi (golimumab) among patients with PsA who have an inadequate response to a TNFi.
- Interventions: guselkumab, golimumab
- Primary Outcome Measures: Achievement of cDAPSA low disease activity; Investigator global assessment of psoriasis of clear or almost clear.
- Time Frames: 12 months; 12 months.
- Study Details
- Source
Related Guidance:
- Management of Psoriatic Arthritis with Pharmacological Therapies
- European League Against Rheumatism (EULAR), March 2024
- Psoriatic Arthritis Assessment and Treatment
- Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), June 2022
- Treatment of Psoriatic Arthritis
- American College of Rheumatology (ACR) / National Psoriasis Foundation (NPF), November 2018
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